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Journal of Cardiovascular Magnetic Resonance

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Open Access 01-12-2012 | Study protocol

Design and rationale of the MR-INFORM study: stress perfusion cardiovascular magnetic resonance imaging to guide the management of patients with stable coronary artery disease

Authors: Shazia T Hussain, Matthias Paul, Sven Plein, Gerry P McCann, Ajay M Shah, Michael S Marber, Amedeo Chiribiri, Geraint Morton, Simon Redwood, Philip MacCarthy, Andreas Schuster, Masaki Ishida, Mark A Westwood, Divaka Perera, Eike Nagel

Published in: Journal of Cardiovascular Magnetic Resonance | Issue 1/2012

Abstract

Background

In patients with stable coronary artery disease (CAD), decisions regarding revascularisation are primarily driven by the severity and extent of coronary luminal stenoses as determined by invasive coronary angiography. More recently, revascularisation decisions based on invasive fractional flow reserve (FFR) have shown improved event free survival. Cardiovascular magnetic resonance (CMR) perfusion imaging has been shown to be non-inferior to nuclear perfusion imaging in a multi-centre setting and superior in a single centre trial. In addition, it is similar to invasively determined FFR and therefore has the potential to become the non-invasive test of choice to determine need for revascularisation.

Trial design

The MR-INFORM study is a prospective, multi-centre, randomised controlled non-inferiority, outcome trial. The objective is to compare the efficacy of two investigative strategies for the management of patients with suspected CAD. Patients presenting with stable angina are randomised into two groups: 1) The FFR-INFORMED group has subsequent management decisions guided by coronary angiography and fractional flow reserve measurements. 2) The MR-INFORMED group has decisions guided by stress perfusion CMR. The primary end-point will be the occurrence of major adverse cardiac events (death, myocardial infarction and repeat revascularisation) at one year. Clinical trials.gov identifier NCT01236807.

Conclusion

MR INFORM will assess whether an initial strategy of CMR perfusion is non-inferior to invasive angiography supplemented by FFR measurements to guide the management of patients with stable coronary artery disease. Non-inferiority of CMR perfusion imaging to the current invasive reference standard (FFR) would establish CMR perfusion imaging as an attractive non-invasive alternative to current diagnostic pathways.

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Title: Design and rationale of the MR-INFORM study: stress perfusion cardiovascular magnetic resonance imaging to guide the management of patients with stable coronary artery disease
Authors: Shazia T Hussain
Matthias Paul
Sven Plein
Gerry P McCann
Ajay M Shah
Michael S Marber
Amedeo Chiribiri
Geraint Morton
Simon Redwood
Philip MacCarthy
Andreas Schuster
Masaki Ishida
Mark A Westwood
Divaka Perera
Eike Nagel
Publication date: 01-12-2012
Publisher: BioMed Central
Published in: Journal of Cardiovascular Magnetic Resonance / Issue 1/2012
Electronic ISSN: 1532-429X
DOI: https://doi.org/10.1186/1532-429X-14-65

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Design and rationale of the MR-INFORM study: stress perfusion cardiovascular magnetic resonance imaging to guide the management of patients with stable coronary artery disease

Abstract

Background

Trial design

Conclusion

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Trial design

Conclusion

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